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Restoril pill. Restoril (Temazepam): Uses, Side Effects, Interactions, and Dosage Guide

What is Restoril and how does it work. What are the common side effects of Restoril. How should Restoril be taken for optimal results. What precautions should be considered when using Restoril. How does Restoril compare to other sleep medications.

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Understanding Restoril: A Comprehensive Overview

Restoril, also known by its generic name temazepam, is a prescription medication primarily used for the short-term treatment of insomnia. It belongs to a class of drugs called benzodiazepines, which work by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that promotes relaxation and sleep in the brain.

Restoril is typically prescribed for individuals who have difficulty falling asleep or staying asleep throughout the night. It is generally recommended for short-term use, usually 7 to 10 days, as prolonged use can lead to dependence and tolerance.

Key Features of Restoril

  • Active ingredient: Temazepam
  • Drug class: Benzodiazepine
  • Available forms: Oral capsules
  • Common dosages: 7.5 mg, 15 mg, 22.5 mg, and 30 mg
  • Onset of action: 30 minutes to 1 hour
  • Duration of effect: 6 to 8 hours

Indications and Uses of Restoril

Restoril is primarily indicated for the treatment of insomnia. It can help patients who struggle with:

  • Difficulty falling asleep
  • Frequent nighttime awakenings
  • Early morning awakenings
  • Non-restorative sleep

While Restoril is effective for short-term use, it is not recommended for long-term treatment of chronic insomnia. For persistent sleep issues, healthcare providers may explore alternative treatments or underlying causes of sleep disturbances.

Off-label Uses

In some cases, Restoril may be prescribed off-label for other conditions, such as:

  • Anxiety disorders
  • Alcohol withdrawal symptoms
  • Seizure disorders

It’s important to note that off-label use should only be under the guidance of a healthcare professional who has carefully weighed the potential benefits and risks.

Dosage and Administration Guidelines

The appropriate dosage of Restoril can vary depending on several factors, including age, health status, and the severity of insomnia. It’s crucial to follow the prescribing physician’s instructions carefully.

Typical Dosage Recommendations

  • Adults: 7.5 mg to 30 mg taken once daily at bedtime
  • Elderly or debilitated patients: 7.5 mg initially, which may be increased if necessary
  • Patients with hepatic impairment: Lower doses may be recommended

Restoril should be taken immediately before bedtime and only when a full night’s sleep (7-8 hours) is possible. Taking the medication with or immediately after a high-fat meal may delay its effects.

Important Dosing Considerations

  1. Do not exceed the prescribed dose or take Restoril for longer than recommended.
  2. Avoid abrupt discontinuation, as this may lead to withdrawal symptoms.
  3. If a dose is missed, skip it and resume the regular dosing schedule the next night.
  4. Never take a double dose to make up for a missed one.

Common Side Effects and Adverse Reactions

While Restoril can be effective in treating insomnia, it may cause various side effects. It’s essential to be aware of these potential adverse reactions and report any concerning symptoms to a healthcare provider.

Frequently Reported Side Effects

  • Drowsiness or daytime sedation
  • Dizziness
  • Lightheadedness
  • Coordination problems
  • Headache
  • Nausea
  • Dry mouth
  • Confusion
  • Memory problems

Most side effects are mild and tend to diminish as the body adjusts to the medication. However, if side effects persist or worsen, it’s important to consult a healthcare professional.

Serious Adverse Reactions

While rare, some individuals may experience more severe side effects that require immediate medical attention:

  • Severe allergic reactions (anaphylaxis)
  • Respiratory depression
  • Suicidal thoughts or behaviors
  • Unusual changes in mood or behavior
  • Hallucinations
  • Severe confusion or disorientation

If any of these serious side effects occur, seek medical help immediately.

Drug Interactions and Precautions

Restoril can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform healthcare providers about all medications, supplements, and herbal products being used.

Common Drug Interactions

  • Other central nervous system depressants (e.g., opioids, alcohol)
  • Certain antidepressants (e.g., SSRIs, SNRIs)
  • Antihistamines
  • Antipsychotics
  • Anticonvulsants
  • CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)

These interactions may increase sedation, impair cognitive function, or affect breathing. Always consult a healthcare provider or pharmacist before starting or stopping any medication while taking Restoril.

Special Precautions

Certain populations may be at higher risk for adverse effects and should use Restoril with caution:

  • Elderly patients
  • Individuals with a history of substance abuse
  • Patients with respiratory disorders
  • Those with liver or kidney impairment
  • Pregnant or breastfeeding women

Healthcare providers will carefully consider the risks and benefits of prescribing Restoril in these situations.

Comparing Restoril to Other Sleep Medications

While Restoril is effective for many individuals, it’s not the only option for treating insomnia. Understanding how it compares to other sleep medications can help patients and healthcare providers make informed decisions.

Restoril vs. Ambien (Zolpidem)

  • Both are used for short-term insomnia treatment
  • Ambien is a non-benzodiazepine hypnotic, while Restoril is a benzodiazepine
  • Ambien may have a faster onset of action
  • Restoril may be more effective for sleep maintenance

Restoril vs. Lunesta (Eszopiclone)

  • Lunesta is also a non-benzodiazepine hypnotic
  • Lunesta may be prescribed for longer periods than Restoril
  • Both can be effective for sleep onset and maintenance
  • Lunesta may have a lower risk of next-day impairment

The choice between these medications depends on individual patient factors, including the specific nature of their sleep problems, medical history, and potential drug interactions.

Potential for Dependence and Withdrawal

As a benzodiazepine, Restoril carries a risk of physical and psychological dependence, especially with prolonged use or higher doses. Understanding this potential is crucial for patients and healthcare providers.

Signs of Dependence

  • Needing higher doses to achieve the same effect (tolerance)
  • Experiencing withdrawal symptoms when stopping the medication
  • Continued use despite negative consequences
  • Difficulty controlling use or cutting down

Withdrawal Symptoms

Abruptly stopping Restoril after regular use can lead to withdrawal symptoms, which may include:

  • Rebound insomnia
  • Anxiety and irritability
  • Tremors
  • Sweating
  • Nausea and vomiting
  • In severe cases, seizures or hallucinations

To minimize the risk of withdrawal, healthcare providers typically recommend a gradual tapering of the dose when discontinuing Restoril, especially after long-term use.

Non-Pharmacological Approaches to Insomnia Management

While Restoril can be effective for short-term insomnia treatment, it’s often recommended in conjunction with non-pharmacological approaches. These strategies can help improve sleep quality and may reduce the need for medication over time.

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is considered the gold standard for non-pharmacological insomnia treatment. It typically involves:

  • Sleep hygiene education
  • Stimulus control therapy
  • Sleep restriction
  • Relaxation techniques
  • Cognitive restructuring

Lifestyle Modifications

Simple changes in daily habits can significantly improve sleep quality:

  • Maintaining a consistent sleep schedule
  • Creating a relaxing bedtime routine
  • Optimizing the sleep environment (temperature, noise, light)
  • Limiting caffeine and alcohol intake, especially in the evening
  • Regular exercise (but not too close to bedtime)
  • Managing stress through techniques like meditation or yoga

Combining these non-pharmacological approaches with Restoril, when prescribed, can lead to more comprehensive and sustainable improvements in sleep quality.

Monitoring and Follow-up for Restoril Use

Regular monitoring is essential when using Restoril to ensure its effectiveness and safety. Healthcare providers typically schedule follow-up appointments to assess the medication’s impact and address any concerns.

Key Aspects of Monitoring

  • Evaluating sleep quality and daytime functioning
  • Assessing for side effects or adverse reactions
  • Checking for signs of dependence or tolerance
  • Reviewing the need for continued treatment
  • Considering dose adjustments if necessary

Patients should keep a sleep diary and note any changes in sleep patterns or overall well-being to discuss with their healthcare provider during these follow-ups.

Long-term Considerations

For patients who require longer-term treatment for insomnia, healthcare providers may:

  • Explore alternative medications or treatment approaches
  • Implement intermittent dosing schedules to minimize dependence risk
  • Emphasize non-pharmacological strategies for sleep improvement
  • Consider referral to a sleep specialist for comprehensive evaluation

Open communication between patients and healthcare providers is crucial for optimizing the use of Restoril and managing insomnia effectively over time.

Restoril Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also Warning section.

Dizziness or difficulty with coordination may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (“sleep-driving”). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking temazepam.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Temazepam Uses,Images & Side effects

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capsule, blue, imprinted with FOR SLEEP M, M RESTORIL 22.5 mg

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capsule, blue/pink, imprinted with RESTORIL 7.5 mg, M FOR SLEEP

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capsule, blue, imprinted with 22. 5 mg 22.5 mg, M FOR SLEEP

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Restoril 15 mg

capsule, peach/red, imprinted with RESTORIL 15 MG, FOR SLEEP

Restoril 30 mg

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Temazepam 30 mg-MYL

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Temazepam 30 mg-PUR

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Temazepam 7. 5 mg-GG

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Differences, similarities, and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

Restoril and Ambien are two prescription medications used in the treatment of insomnia. Insomnia is a sleeping disorder characterized by having trouble falling asleep, staying asleep, or getting good quality sleep. A lack of sleep can leave patients feeling sleepy and unrested, making daily activities difficult.

Insomnia can be categorized two ways: short-term insomnia can last a few days or weeks and is typically brought on by a change in schedule or stressors, and chronic insomnia occurs three or more nights per week over three or more months and cannot be explained by a life change, medication, or other known cause. Healthcare providers may suggest environmental changes and cognitive behavioral therapy prior to beginning sleep aid medications.

Restoril and Ambien both treat forms of insomnia, though they are not the same. We will discuss their differences here.

What are the main differences between Restoril and Ambien?

Restoril (temazepam) is a prescription drug that is used in the treatment of short-term insomnia. It is a benzodiazepine used as a sedative-hypnotic. Benzodiazepines are central nervous system (CNS) depressants. CNS depressants result in many effects including sedation, hypnosis, anticonvulsant, and muscle relaxation. These effects are brought on by non-specific binding to gamma-aminobutyric acid-A (GABA-A) receptors that have multiple omega subunits, each responsible for various effects. Restoril is available as an oral capsule in strengths of 7.5 mg, 15 mg, 22.5 mg, and 30 mg. Restoril is considered a controlled substance by the Drug Enforcement Agency (DEA) because it can be habit-forming and have the potential for abuse.

Ambien (zolpidem) is a prescription drug that is used in the treatment of short-term insomnia, particularly in patients for whom initiating sleep and maintaining sleep is the obstacle. Ambien is a positive modulator at the GABA-A receptor as well but is different from benzodiazepines in that it has a higher affinity specifically for the omega-1 subunit of the GABA-A receptor. Ambien is a non-benzodiazepine sedative-hypnotic. This is thought to explain why Ambien has a somnolent effect, but no effects related to muscle relaxation, anxiety, or seizure activity. Ambien is available as an oral immediate-release tablet in 5 mg and 10 mg, as well as extended-release tablets in 6.25 mg and 12.5 mg. Ambien is also characterized as a controlled substance by the DEA.

Main differences between Restoril and Ambien
Drug classBenzodiazepineNon-benzodiazepine sedative
Brand/generic statusBrand and generic availableBrand and generic available
What is the generic name?TemazepamZolpidem
What form(s) does the drug come in?Oral capsuleOral immediate- and extended-release tablets
What is the standard dosage?30 mg at bedtime10 mg at bedtime
How long is the typical treatment?A few days to weeksMonths
Who typically uses the medication?AdultsAdults

Conditions treated by Restoril and Ambien

Restoril is indicated in the treatment of short-term insomnia. Short-term insomnia typically lasts a few days or weeks and is generally related to a particular stressor or change in sleep schedule.

Ambien, in its immediate-release form, is used in short-term insomnia characterized by difficulty initiating sleep, or falling asleep. Ambien CR, the extended-release formulation, is used to treat insomnia characterized by trouble initiating sleep and/or sleep maintenance or staying asleep.

Short-term insomniaYesYes
Chronic insomnia (with trouble initiating or staying asleep)NoYes

Is Restoril or Ambien more effective?

Restoril and Ambien were compared in a placebo-controlled clinical trial. This trial included more than 600 patients with transient, or short-term, insomnia. While both drugs were shown to improve the efficiency of sleep as compared to placebo, Ambien was superior in reducing the number of awakenings after sleep onset. In other words, patients were less likely to wake up through the night with Ambien as compared to Restoril. Given this information, and taking into consideration that Ambien avoids unwanted effects on muscle relaxation and seizure activity, your prescriber may choose Ambien for your short-term insomnia.

Only your physician can determine which medication is best for you and your particular sleep disorder. This is not intended to be medical advice.

Coverage and cost comparison of Restoril vs. Ambien

Restoril is typically covered by commercial insurance plans, but generally not covered by Medicare drug plans. The out-of-pocket price for Restoril is around $60, but with a coupon from SingleCare, you can lower the generic price to approximately $10 at participating pharmacies.

Ambien is also typically covered by commercial insurance plans, but generally not covered by Medicare drug plans. The out-of-pocket price for brand-name Ambien can run up to $600-$700. SingleCare’s coupon for generic Ambien (zolpidem tartratean) can lower the price to $14 at many pharmacies.

Typically covered by insurance?YesYes
Typically covered by Medicare Part D?No, exceptions are plan dependentNo, exceptions are plan dependent
Quantity30, 30 mg capsules30, 10mg immediate-release tablets
Typical Medicare copayn/an/a
SingleCare cost$10-$37$14-$29

Common side effects of Restoril vs. Ambien

Restoril and Ambien have a significant number of potential side effects. Headache, fatigue, and nervousness are possible with both drugs. Both drugs have the potential to leave patients with a hangover effect or drugged feeling, which can affect daily functioning. It is important to plan to get a minimum of eight hours of sleep after taking these medications in order to help avoid this effect.

Nightmares, vivid dreams, and abnormal dreams are possible with Restoril and Ambien. In some instances, there have been reports of binge eating, sexual activity, and other abnormal activities while patients are reportedly still asleep (sleepwalking). These potential adverse effects should be discussed with your doctor.

This is not intended to list all potential effects of these medications. Your doctor may discuss other possible adverse effects.

Side effectApplicable?FrequencyApplicable?Frequency
DrowsinessYes9.1%Yes8%
HeadacheYes8.5%YesNot defined
FatigueYes4.8%YesNot defined
NervousnessYes4.6%YesNot defined
LethargyYes4. 5%Yes3%
DizzinessYes4.5%Yes5%
Abnormal DreamsNon/aYes1%
NauseaYes3.1%YesNot defined
HangoverYes2.5%Yes3%
AnxietyYes2.0%YesNot defined
DepressionYes1.7%Non/a
Dry MouthYes1.7%Yes3%
DiarrheaYes1.7%Yes3%
Abdominal PainYes1.5%Yes2%
ConstipationNon/aYes2%
EuphoriaYes1.5%YesNot defined
WeaknessYes1.4%Non/a
ConfusionYes1. 3%YesNot defined
Blurred visionYes1.3%Non/a
NightmaresYes1.2%Non/a
VertigoYes1.2%YesNot defined
AllergyNon/aYes4%

Source: Restoril (DailyMed)  Ambien (DailyMed)

Drug interactions of Restoril vs. Ambien

Restoril and Ambien both have CNS depressant effects, and their concomitant use with other CNS depressants may lead to an additive effect, which could be dangerous. Most notably, use with opiate pain relievers can lead to severe respiratory depression and possibly even death. Common opiate pain relievers include codeine, hydrocodone, and oxycodone.

Caffeine, especially if consumed in the time shortly before taking Restoril or Ambien, may counteract the desired effects of Restoril and Ambien. Caffeine is pharmacologically opposite of Restoril and Ambien in that it stimulates the central nervous system.

Commonly used antihistamines, such as Benadryl (diphenhydramine), may also cause significant sleepiness and should not be given with Restoril and Ambien as the additive effect could be dangerous.

This is not intended to be an all-inclusive list of potential drug interactions. Please consult your pharmacist or healthcare professional for a complete list.

Codeine
Hydrocodone
Morphine
Hydromorphone
Oxycodone
Opioid pain relieversYesYes
CaffeineSimulantYesYes
Aripiprazole
Olanzapine
Quetiapine
Atypical antipsychoticsYesYes
Brompheniramine
Chlorpheniramine
Diphenhydramine
Hydroxyzine
Cetirizine
AntihistaminesYesYes
Carisoprodol
Metaxalone
Cyclobenzaprine
Muscle relaxantsYesYes
ClonidineAlpha agonistYesNo
TramadolMu-opioid pain relieverYesYes
TrazodoneAntidepressantYesYes
Amitriptyline
Doxepin Nortriptyline
Imipramine
Tricyclic antidepressantsYesYes
Citalopram
Escitalopram
Fluoxetine
Sertraline
Selective serotonin reuptake inhibitors (SSRIs)NoYes

Warnings of Restoril and Ambien

The use of Restoril and Ambien with other CNS depressants, such as opioid pain relievers, may lead to profound sedation, respiratory depression, coma, and even death. The use of Restoril and Ambien together should be avoided for the same reason.

It is important to note that if insomnia does not improve within seven to 10 days of taking medication, patients should be evaluated for underlying psychiatric disorders that may be contributing to sleep problems if untreated.

Restoril and Ambien should be avoided if a patient has consumed alcohol within a few hours of bed, or does so on a regular basis. The combination leads to psychomotor impairment that can last into the next day, and may impair driving and reflex times.

Before taking Ambien or Restoril, please alert your doctor to any medical conditions or other medications you are taking, including over-the-counter medications and other sleep medications.

Do not suddenly stop taking Restoril or Ambien without consulting your healthcare provider. You might experience withdrawal symptoms such as agitation, anxiety, and depression.

Frequently asked questions about Restoril vs.

Ambien

What is Restoril?

Restoril is a prescription medication used in the treatment of short-term insomnia. It is classified as a benzodiazepine and is also considered a controlled substance by the DEA due to its potential for abuse. It is available as an oral capsule in strengths of 7.5 mg, 15 mg, 22.5 mg, and 30 mg.

What is Ambien?

Ambien is a prescription medication used to treat insomnia. It is a non-benzodiazepine sedative drug but is still considered a controlled substance by the DEA because of its potential for abuse. It is available in immediate-release tablet form in 5 mg and 10 mg strengths. It is also available in extended-release tablet form (Ambien CR) in strengths of 6.25 mg and 12.5 mg.

Are Restoril and Ambien the same?

While both Restoril and Ambien treat insomnia, they are not the same. Restoril is a benzodiazepine that also has effects on muscle relaxation, convulsions, and anxiety. Ambien is not a benzodiazepine and has a more specific receptor target and avoids these effects while targeting insomnia.

Is Ambien or Restoril better?

While both Restoril and Ambien are capable of improving the efficiency of sleep, Ambien has been shown to be significantly better at reducing the number of awakenings after falling asleep. Given this, and the more specific activities toward sleep, Ambien may be preferred over Restoril.

Can I use Restoril or Ambien while pregnant?

Restoril is categorized by the Food and Drug Administration (FDA) as pregnancy category X. It is contraindicated in pregnancy and should not be used. Ambien is pregnancy category C indicating that there have been no well-controlled studies to prove safety and efficacy. Ambien should only be used when benefits clearly outweigh the risks.

Can I use Restoril or Ambien with alcohol?

Patients should avoid taking Restoril or Ambien if they have consumed alcohol in the hours leading up to sleep. Significant psychomotor impairment can result from concomitant use.

What sleeping pill works better than Ambien?

Lunesta (eszopiclone) offers some advantage over Ambien in that it is considered safe to be used long term, whereas Ambien is intended for relatively short-term use. Lunesta has been shown to be highly effective for sleep maintenance.

Does Restoril help with anxiety?

Restoril is a benzodiazepine and does possess anxiolytic effects, making it an effective anti-anxiety medication.

How fast does Restoril work?

Temazepam works within 15 to 30 minutes of taking it and should be taken 15 to 30 minutes prior to the desired time to be asleep.

Temazepam: MedlinePlus Drug Information

Temazepam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take temazepam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Temazepam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with temazepam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Temazepam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping temazepam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your temazepam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

temazepam | Michigan Medicine

What is the most important information I should know about temazepam?

Temazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not use if you are pregnant.

What is temazepam?

Temazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat insomnia (trouble falling or staying asleep).

Temazepam may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking temazepam?

You should not use this medicine if you are allergic to temazepam or similar medicines (such as alprazolam, diazepam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Valium, Versed, Xanax, and others).

Do not use temazepam if you are pregnant. It could harm the unborn baby.

If you use temazepam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Tell your doctor if you have ever had:

  • lung disease or breathing problems;
  • depression, mental illness, suicidal thoughts;
  • alcoholism or drug addiction; or
  • liver or kidney disease.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Temazepam is not approved for use by anyone younger than 18 years old.

How should I take temazepam?

Follow the directions on your prescription label and read all medication guides. Never use temazepam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share temazepam with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking temazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Do not stop using temazepam suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

What happens if I miss a dose?

Since temazepam is used when needed, you may not be on a dosing schedule. Take temazepam only when you have time for several hours of sleep. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of temazepam can be fatal, especially if taken with alcohol.

Overdose symptoms may include extreme drowsiness, confusion, or loss of consciousness.

What should I avoid while taking temazepam?

Do not drink alcohol. Dangerous side effects or death could occur.

You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

What are the possible side effects of temazepam?

Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Temazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if you have:

  • confusion, agitation, hallucinations;
  • depressed mood; or
  • thoughts of suicide or hurting yourself.

Some people using temazepam have engaged in activity such as driving, eating, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines.

Common side effects may include:

  • day-time drowsiness or “hangover” feeling;
  • headache;
  • dizziness, tiredness;
  • nausea; or
  • feeling nervous.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect temazepam?

Taking temazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect temazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about temazepam.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2021 Cerner Multum, Inc. Version: 11.01. Revision date: 12/8/2020.

How Long Does Restoril (Temazepam) Stay in Your System?

Restoril (temazepam) is a medication that slows the activity of your brain. It is prescribed as a short-term sleeping aid for people with insomnia. As it can be habit-forming, it is not usually prescribed for longer than 10 days.

Restoril is in a class of drugs called benzodiazepines, which are central nervous system depressants and Schedule IV controlled substances. When combined with other depressants or alcohol, or when taken in large dosages, Restoril can cause a loss of consciousness and respiratory failure.

To avoid negative drug interactions, it’s important to know how long the medication will stay in your system. Restoril can be detected in your body from one to 90 days, depending on factors like dosage, age, weight, and metabolism, as well as the type of detection test used.

How Long Does Restoril Stay in Your System?

Blood: Up to 24 hours

Urine: Up to one week

Saliva: Up to 24 hours

Hair: Up to 90 days

How Long Does It Take to Feel the Effects?

Restoril is classified as a short- to intermediate-acting benzodiazepine. It begins to work in 10 to 20 minutes after you take a dose. The levels of the medication will peak about one and a half hours later.

It’s recommended that you only take Restoril if you are able to stay in bed for seven to eight hours before you have to get up again (which is about how long you will be affected by the medication).

Restoril Side Effects

Common side effects of Restoril include:

  • Anxiety
  • Depression
  • Dizziness
  • Drowsiness
  • Dry mouth
  • Feeling groggy the next day
  • Headache
  • Lethargy
  • Nausea
  • Nervousness

While it is uncommon, you might experience sleepwalking while you are taking Restoril. Episodes of sleepwalking can include engaging in activities such as driving, cooking, talking on the phone, and having sex with no memory of having done these things.

Tell your healthcare provider about any side effects you experience that get worse or do not go away.

How Long Does Restoril Last?

The half-life of a drug is the time it takes for half the drug to be eliminated from your system. It takes five to seven half-lives to clear out 98% of a drug dose. The amount of time a benzodiazepine remains in your system partly depends on what type it is: ultra-short, short, intermediate, or long-acting.

Ultra-short benzodiazepines have a half-life of fewer than five hours, while short- to intermediate-acting benzodiazepines like Restoril have a half-life from five to 24 hours. Long-acting benzodiazepines have a half-life exceeding 24 hours.

The average half-life of Restoril is around 9 hours.

Restoril is metabolized by your liver with a half-life in two phases—one short and one long. Most of the drug is excreted in your urine. In general, the typical detection windows for benzodiazepines are different for urine, blood, and saliva, and hair.

Urine

A typical therapeutic dose of Restoril will appear positive on a urine drug screen (such as those done for employment purposes) for an average of five days to a week. Heavier or longer use of the medication can create a positive urine test for weeks.

Blood

Restoril clears out of your bloodstream much faster than it does from your urine. It is usually only detectable in blood for up to 24 hours.

Saliva

Restoril can be detectable in your saliva for 24 hours or longer.

Hair

As with all drugs, Restoril can be detected in your hair. The range of detection for Restoril starts at about two to three weeks after you take the medication and can go up to three months after your last dose.

False Positive Testing

Certain medications may cause a false positive urine screen for Restoril. The antidepressant medication Zoloft (sertraline) and prescription non-steroidal anti-inflammatory drug Daypro (oxaprozin) reportedly can cause a false-positive urine test for benzodiazepines like Restoril.

Certain medications, including some antidepressants, can cause a false-positive result for Restoril on a drug screen.

If you are taking Restoril and need to take a drug screening for work, tell the testing laboratory before giving a sample. This will help them interpret your results. You might also want to inform your employer (or prospective employer) that you’re taking Restoril ahead of time.

Factors That Affect Detection Time

How long Restoril is detectable in your body depends on many variables, including your metabolism, weight, amount of body fat, and hydration status. The amount of Restoril that you take and how long you have been taking it, as well as the type of test that is used, will also affect your results.

Age

Your age can play a factor in the half-life of Restoril. The average half-life of the drug is higher for healthy older adults than it is for healthy young adults.

Weight

Being overweight makes it more difficult for your body to eliminate Restoril, which can increase the half-life of the drug. 

Metabolism

People who have a higher metabolism (which can be influenced by hydration, age, activity level, and other health conditions) tend to be able to excrete Restoril faster than people with a slower metabolic rate.

Alcohol Use

Combining alcohol and Restoril can cause a fatal overdose. Alcohol can increase Restoril’s sedative effects as well as make it harder for your body to break down the drug.

Symptoms of Overdose

Restoril can be habit-forming. It’s important to take the medication according to the schedule and dosage that your healthcare provider has prescribed. Misuse of Restoril can lead to symptoms of an overdose, such as:

  • Confusion
  • Dizziness
  • Difficulty breathing
  • Drowsiness
  • Loss of consciousness

If you think someone has overdosed on Restoril, call poison control at 1-800-222-1222. If the person has a seizure, loses consciousness, or has difficulty breathing, call 911.

Allergic Reactions

It is also possible to develop a severe allergic reaction to Restoril. Symptoms of an allergic reaction can include:

  • Difficulty breathing or swallowing
  • Hives
  • Hoarseness
  • Rash
  • Swelling of your face

If you are taking Restoril and have symptoms of an allergic reaction, go to your nearest emergency room or call 911.

Drug Interactions

You should avoid drinking alcohol, using street drugs, or taking opiates (such as codeine, hydrocodone, fentanyl, hydromorphone, meperidine, methadone, morphine, oxycodone, or tramadol) while you are taking Restoril.

Combing Restoril with these medications and substances increases your risk of developing life-threatening breathing problems, sedation, coma, or death.

Other drugs that can potentially cause negative interactions with Restoril include:

To avoid potentially serious drug interactions, it’s important that you tell your doctor about all the medications you are taking. This includes any over-the-counter (OTC) drugs, herbal supplements, vitamins, or alternative remedies.

Getting Help

If you need or want to stop taking Restoril, you need to taper off the drug gradually and under the guidance of your doctor. If you suddenly stop taking Restoril, you may experience symptoms of benzodiazepine withdrawal. Withdrawal symptoms can range from mild to severe and can include:

  • Depressed mood
  • Seizures
  • Shakiness
  • Stomach and muscle cramps
  • Sweating
  • Trouble sleeping
  • Vomiting

Restoril is safe for most people who take it as prescribed. However, people who have a history of alcohol or substance use disorders might be at an increased risk for misuse or addiction when taking Restoril.

New users of sleeping pills like Ambien, Restoril, Desyrel, have more car crashes

Sedative sleeping pills such as Ambien can nearly double the risk for car accidents among new users compared with nonusers, new research suggests.

University of Washington researchers found an increased risk for crashes for people taking Restoril (temazepam), Desyrel (trazodone) or Ambien (zolpidem).

That risk continued for up to a year among regular users, according to the study.

“Risks associated with sleeping pills have been known for some time, though this study shows some compelling real-world consequences,” said Michael Grandner, an instructor in psychiatry at the University of Pennsylvania in Philadelphia, who had no involvement with the study.

Doctors, pharmacists and patients should discuss this potential risk when selecting a sleep medication, the researchers said.

Concerns about Ambien have increased in recent years. To cut down on hazards linked to daytime drowsiness, the U.S. Food and Drug Administration in 2013 required lower recommended doses of Ambien products, labeling changes and a recommendation to avoid driving the day after taking extended-release Ambien CR.

“This finding is shockingly not shocking. Sleeping pills are a huge problem,” said Dr. Christopher Winter, a spokesman for the American Academy of Sleep Medicine.

“This study screams that many doctors do not know how to treat sleep patients,” he said. “You have to develop a plan to deal with their sleep, not merely sedate them.”

The recommended first-line treatment for insomnia is not medication, but cognitive behavioral therapy, Grandner said. This type of talk therapy “uses a set of tools to change your schedule and essentially reprogram your brain for sleep,” he explained.

Cognitive behavioral therapy is effective and much safer than many prescription sleeping medications, Grandner said. “If you have severe insomnia, you may wish to seek out an insomnia specialist who is trained to fix these sorts of problems without sleeping medications,” he added.

For the new report, published online June 11 in the American Journal of Public Health, Ryan Hansen of the University of Washington in Seattle, and colleagues looked at prescription records and motor vehicle crash records of more than 400,000 Washington state drivers who had a drug benefit in the Group Health Cooperative insurance plan. Participants were followed until death, unenrollment or the study’s end.

Trazodone — an antidepressant used for insomnia — was the most commonly prescribed sedative, followed by temazepam (Restoril) and zolpidem (Ambien), the findings showed.

Of the three drugs, which are all considered sedative hypnotic medications, temazepam appeared to have the least risk for crashes, the study found.

Overall, the risk of crashing related to use of these sedatives was similar to the crash risk associated with driving drunk, the researchers said.

The trouble, Winter said, is that Americans are fixated on sleep and getting to sleep fast. They may not realize that many sleeping pills are addictive and can worsen the quality of your sleep, he added.

Sleeping pills have their uses, Winter acknowledged. They can help people who have suffered a tragic event or need to adjust to a new work schedule, but they should not become a regular habit, he said.

Someone who has a couple of nights of bad sleep shouldn’t panic, Winter said. It is worry about not sleeping that adds to sleep problems and can perpetuate insomnia, he explained.

“There is no harm to insomnia,” he added.

“Maybe my night will be terrible and maybe I’ll be sleepy tomorrow,” is how Winter looks at a restless night. “I can deal with that. By the next night my sleep will be fine.”

Rivotril :: Instruction :: Price :: Description of the drug

Rivotril

Rivotril tablets and solution are based on clonazepam.

Auxiliary components of the tablets are lactose, corn and potato starch, iron dioxide, talc, iron trioxide, magnesium stearate, MCC.

Additional components of the solution are absolute alcohol, benzyl alcohol, glacial acetic acid, propylene glycol, water for injection.Water for injection is attached to the preparation as a solvent.

Benzodiazepine anticonvulsant drug – Rivotril, has a therapeutic effect due to the main component clonazepine. The drug enhances the effect of gamma-aminobutyric acid, slowing down the transmission of nerve impulses, reduces the excitability of the cerebral subcortex and the rate of postsynaptic spinal reflexes. Presynaptic inhibition helps prevent the spread of epileptogenic activity without affecting excitation in the focus.

The anxiolytic effect of Rivotril is manifested in the reduction of emotional stress, anxiety, anxiety and fear by interacting with the amygdala complex. Influencing the nonspecific nuclei of the optic tubercle and the reticular formation, the drug reduces neurotic symptoms.

In addition to the anticonvulsant effect, Rivotril has a muscle relaxant, hypnotic and sedative effect.

Rivotril, as an agent of the first row, is indicated for use in epilepsy: atypical and typical absences, nodding convulsions, atonic seizures.

As an agent of the second row, the drug is indicated for the treatment of infantile spasms.

For tonic-clonic seizures, partial seizures, secondary generalized convulsive seizures, Rivotril is used as a third-line remedy.

In case of status epilepticus, intravenous administration of the medication is indicated.

The use of Rivotril is indicated for somnambulism, muscle hypertonia, psychomotor agitation, insomnia, alcohol withdrawal, panic attacks.

Rivotril tablets are intended for oral administration, solution – for intravenous administration. The effective dose is calculated individually. The daily dose is divided into 3-4 applications. Supportive therapy is started 14–21 days after the start of treatment. When administered intravenously, a single dose is 1 mg for adults and 500 mcg for children. For parenteral administration, Rivotril should be diluted with the supplied diluent.

Adults at the beginning of therapy are shown to use 1 mg / day., the maintenance dose is 4–8 mg / day.

For children from 1 to 5 years of age, treatment begins with the use of up to 250 mcg / day, over 5 years – 500 mcg / day. Supportive therapy consists in the use of 0.5-1 mg / day for children under one year old, 1-3 mg / day for 1-5 years, 3-6 mg / day for 5-12 years.

Elderly patients start treatment with 500 mcg / day.

Treatment with Rivotril often provokes the development of headache, lethargy, increased fatigue, drowsiness, dizziness, lethargy, numbness.

Hypotension, agranulocytosis, tachycardia, respiratory depression, leukopenia, anemia, thrombocytopenia, neutropenia, transient alopecia develop infrequently with the use of the drug.

Rarely, the use of Rivotril contributes to the development of ataxia, liver dysfunction, confusion, articulation disturbances, diplopia, paradoxical reactions, hyperergic reactions, dry mouth, nystagmus, nausea, stool disorders, decreased appetite, dysmenorrhea, changes in libido, renal dysfunction, allergic reactions, changes in pigmentation, anterograde amnesia, urinary incontinence.

For children, the characteristic side symptoms are increased salivation, bronchial hypersecretion, premature puberty.

With a sharp withdrawal of Rivotril, withdrawal syndrome develops.

Rivotril should not be used for myasthenia gravis, respiratory depression, acute alcohol intoxication, severe forms of COPD, severe depression, acute respiratory failure, coma, angle-closure glaucoma, poisoning with hypnotics and narcotic analgesics, shock.

The drug is contraindicated in case of allergy to the components of dosage forms.

Rivotril is prohibited to use for the treatment of premature and newborn babies.

The use of Rivotril during pregnancy is prohibited.

Do not breastfeed during antiepileptic treatment.

The depressing effect of Rivotril on the central nervous system is enhanced by the use of drugs with the same effect and ethanol.

The effect of muscle relaxants is enhanced by treatment with Rivotril.

Rivotril reduces the effects of sodium valproate and can cause seizures.

Rivotril affects the pharmacological action of desipramine.

The metabolism of Rivotril is accelerated by treatment with carbamazepine.

The use of caffeine reduces the effect of Rivotril.

The concentration of Rivotril decreases with the use of lamotrigine.

The likelihood of developing neurotoxicity and pathologies of the central nervous system increases with treatment with Rivotril with lithium carbonate and cimetidine.

The concentration of primidone and toremifene is reduced by the action of Rivotril.

The likelihood of developing headache increases with the treatment of Rivotril with phenelzine.

Exceeding the dose of Rivotril is manifested by depression of the central nervous system, drowsiness, confusion, depression of respiration and reflexes, coma.

Rivotril is available in the form of a solution and tablets.

Clonazepam 0.5 or 2 mg tablets are packaged in darkened glass vials. The package can contain 50 tablets of 0.5 mg, 30 or 100 tablets of 2 mg.

Solution for intravenous administration of 1 mg of clonazepam in 1 ml is poured into 1 ml ampoules. One package consists of 5 ampoules with medication and ampoules with solvent.

Up to +25 degrees Celsius, protected from moisture and light, out of the reach of children.

Clonazepam, Clonotril.

See also the list of analogues of the drug Rivotril.

Status epilepticus (G41)

N03AE01

F.Hoffmann-La Roche

Country of origin – Switzerland.

The manual was compiled by a team of authors and editors of the Piluli website. The list of authors of the reference book of medicines is presented on the page of the site editorial office: Site editorial board.

References to used sources of information.

Description of the drug “ Rivotril ” on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult with your doctor and familiarize yourself with the annotation approved by the manufacturer.
Information on the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the doses and methods of its use.

Views: 29203.

Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects, and when you should contact your healthcare provider.

Trade names: USA

KlonoPIN

Trade names: Canada

APO-ClonazePAM; Clonapam; CO ClonazePAM [DSC]; DOM-ClonazePAM [DSC]; DOM-ClonazePAM-R [DSC]; MYLAN-ClonazePAM [DSC]; PMS-ClonazePAM; PMS-ClonazePAM-R; PRO-ClonazePAM; RIVA-ClonazePAM; Rivotril; SANDOZ ClonazePAM [DSC]; TEVA-ClonazePAM [DSC]

Warning

  • This drug is a benzodiazepine. Concomitant use of benzodiazepines with opioids has resulted in very severe side effects.Side effects observed included slowing or difficult breathing and death. Opioids include drugs such as codeine, oxycodone, and morphine. Opioids are used to treat pain and some are used to treat coughs. Consult your doctor.
  • If you are taking this drug with an opioid, get medical help right away if you feel very sleepy or dizzy, if you have slow, shallow, or difficult breathing, or if you pass out.Caregivers or others should seek immediate medical attention if the patient does not respond, does not respond or does not respond normally, or if he is asleep and does not wake up.
  • There may be a risk of dependence, abuse or misuse when using benzodiazepines. Misuse or abuse of this medication can lead to overdose or death, especially when used in conjunction with certain other drugs, alcohol, or drugs.Addiction can occur even if you use this drug as directed by your doctor. Get immediate medical attention if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.
  • You will be closely monitored to avoid misuse, abuse or dependence on this drug.
  • Benzodiazepines may be addictive.Reducing the dose or stopping suddenly from this drug may cause withdrawal. This can be life threatening. The risk of addiction and withdrawal increases with long-term or high-dose use of this drug. Talk to your doctor before lowering the dose or stopping this drug. Follow your doctor’s instructions. Seek immediate medical attention if you experience problems controlling body movements, seizures, behavior or mood changes, such as depression or suicidal thoughts, thoughts of harming someone, hallucinations (vision or auditory perception), appear or become more severe non-existent things), loss of contact with reality, stupid movements or conversations, or any other side effects.
  • Sometimes withdrawal symptoms can last from several weeks to more than 12 months. Tell your doctor if you have anxiety; problems with memory, learning, or concentration; sleep problems; burning, numbness, or tingling; weakness; tremor; muscle twitching; ringing in the ears or any other side effects.

What is this drug used for?

  • Used to treat seizures.
  • Used to treat panic attacks.
  • This drug may be used for other indications. Consult your doctor.

What do I need to tell my doctor BEFORE taking this drug?

  • If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.
  • In one of the following: glaucoma or liver disease.
  • If you are breastfeeding.Do not breast-feed while taking this drug.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking.Do not start or stop taking any drug or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

For all purposes of this product:

  • Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
  • With long-term use of the drug, a blood test should be performed.Talk to a medical professional.
  • Avoid driving or other activities that require increased attention until you see how this drug affects you.
  • If you have had seizures in the past, this drug may cause fainting. Use with care. Do not engage in activities that are unsafe in the event of fainting, such as driving or swimming.
  • If you have lung disease, talk to your doctor.You may be more sensitive to the drug.
  • Avoid drinking alcohol while taking this drug.
  • Talk to your doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow you down.
  • If this drug stops working for you, tell your doctor. Do not take the drug in higher doses than your doctor prescribed.
  • If you have phenylketonuria, talk to your doctor.Some foods contain phenylalanine.
  • If you are 65 years of age or older, use this drug with caution. You may have more side effects.
  • When used during pregnancy, especially during the first trimester, the drug may have a harmful effect on the fetus.
  • Taking this drug late in pregnancy may increase the risk of breathing or eating problems, low body temperature, or withdrawal symptoms in the newborn.Please consult your doctor.
  • If you are pregnant or get pregnant while taking this drug, call your doctor right away.

Anti-seizure:

  • Talk to your doctor if your seizures change or get worse after you start taking this drug.
  • Do not change dosage or discontinue treatment. This can cause seizures. Talk to a medical professional.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can cause serious and sometimes deadly side effects. Call your healthcare professional or get medical attention right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

  • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Balance change.
  • Confusion of consciousness.
  • Violation or loss of memory.
  • Nightmares.
  • Hallucinations (a person sees or hears something that is not in reality).
  • Like other drugs used to treat seizures, this drug in rare cases may increase the risk of suicidal ideation or behavior. This risk may be higher in people who have attempted suicide or have had suicidal thoughts in the past.See your doctor right away if you develop or worsen symptoms such as depression, nervousness, anxiety, irritability, panic attacks, or other mood or behavior disorders. In case of suicidal thoughts or attempted suicide, contact your doctor immediately.

What are some other side effects of this drug?

Any medicine can have side effects. However, many people have little or no side effects.Call your doctor or get medical help if these or any other side effects bother you or do not go away:

  • Feeling dizzy, sleepy, tired, or weak.
  • Increased salivation.
  • Signs of a cold.

This list of potential side effects is not comprehensive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

Tablets:

  • Swallow whole with a full glass of water.

Lozenge:

  • Do not touch the preparation with wet hands.
  • Place the tablet on your tongue and let it dissolve. You do not need to drink water. Do not swallow the tablet whole. Do not chew, crush, or crush the tablet.
  • If tablets are supplied in a foil blister, do not squeeze the tablet out of the foil when opening.The tablet should be removed from the foil with dry hands.

What to do if a dose of a drug is missed?

  • Take the missed dose as soon as you can.
  • If it is time for your next dose, do not take the missed dose and then return to your normal dose.
  • Do not take 2 doses at the same time or an additional dose.

How do I store and / or discard this drug?

All forms of issue:

  • Store at room temperature in a dry place.Do not store in the bathroom.
  • Store this medication in a protected place, out of the reach of children, and out of the reach of other people. A box or room, which is locked with a key, can act as a protected storage location for the drug. Keep all medicines out of the reach of pets.
  • Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so.If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

Lozenge:

  • Protect from light.
  • If this medicine is packaged in a foil bag, store it in this container until use.
  • Use orally disintegrating tablets immediately after opening the pack. Throw away all unused portions from the opened bag.

General information about medicines

  • If your health does not improve or even worsens, see your doctor.
  • Do not give your medicine to anyone or take other people’s medicines.
  • Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
  • A separate patient instruction sheet is included with the product. Please read this information carefully. Reread it every time you replenish your supply. If you have questions about this drug, talk with your doctor, pharmacist, or other healthcare professional.
  • If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Arpimed

Possible side effects

Like all medicines, clonazepam can cause side effects, although not everybody gets them.

Important side effects :

Allergic reactions .

If you develop an allergic reaction, see your doctor immediately.

Allergic reactions can manifest as the following symptoms:

  • Sudden edema of the larynx, face, lips and mouth. These symptoms can lead to difficulty breathing or swallowing.
  • Sudden swelling of the hands, feet and ankles.
  • Skin rash or itching.

Adverse reactions from the cardiovascular system

If you develop any of these symptoms, you should see your doctor immediately.

These symptoms include:

  • Shortness of breath, ankle swelling, cough, fatigue and heart palpitations.
  • Pain in the chest area, which can radiate to the neck, shoulder and left arm.

Adverse reactions from the nervous system

If you develop any of these symptoms, you should talk to your doctor.

These symptoms include:

  • Feelings of aggression, excitement, irritability, nervousness, agitation, anxiety and hostility.
  • Sleep disturbance, nightmares and vivid dreams.
  • Hallucinations, mania and speech impairment.
  • Development of new types of seizures that were not previously observed

Children and babies

  • Special supervision should be observed when taking clonazepam in children and infants, as clonazepam can lead to the development of impaired airway function, coughing and a feeling of suffocation.It can be caused by excessive salivation.
  • Early puberty possible. After the cancellation of clonazepam, this process stops.

Other possible side effects

Taking clonazepam can lead to the following symptoms:

  • Sleepiness and fatigue
  • Dizziness and fatigue.
  • Muscle weakness or flexibility, jerking movements (poor coordination of movements)
  • Instability when walking

If you have any of these symptoms, tell your doctor.Your doctor will prescribe a low dose if necessary, gradually increasing your clonazepam dose.

The following symptoms may appear at any time clonazepam treatment

Mental activity and nervous system

  • Impaired concentration, confusion and feelings of loss (disorientation)
  • Feeling anxious
  • Difficulty remembering new things
  • Headache
  • Depression
  • Slow or choppy speech
  • Poor coordination of movements, including unsteadiness when walking
  • Increase in the incidence of epileptic seizures

Circulatory, renal and hepatic system

  • Liver dysfunction (diagnosed by laboratory liver tests)
  • Uncontrolled urination
  • Problems with the circulatory system.Symptoms include feeling tired, bruising from minor concussions, shortness of breath, and nosebleeds.

Your healthcare professional should perform periodic blood tests as needed.

Gastrointestinal tract

  • Nausea
  • Stomach disorders

Visual organs

  • Diplopia (double vision)
  • Involuntary oscillatory movements (nystagmus)

Respiratory system

  • Respiratory failure (respiratory depression).The first signs include sudden noisy, labored, and irregular breathing. The development of cyanosis of the skin is possible.

Skin and hair

  • Skin rash, urticaria and pruritus.
  • Skin discoloration
  • Hair loss

Genital system

  • Decreased libido
  • Erectile dysfunction

Withdrawal syndrome

When benzodiazepines such as clonazepam are taken, drug dependence may develop.Therefore, with a sudden discontinuation or dose reduction of clonazepam, withdrawal syndrome may develop. Withdrawal can lead to the following symptoms:

  • Sleep disorders
  • Muscle pains, tremors and anxiety
  • Feelings of increased anxiety, tension, irritability or anxiety, or mood changes
  • Increased sweating
  • Headache

Less common symptoms are:

  • Increased sensitivity to light, noise and physical contact
  • Hallucinations
  • Tingling and numbness of hands and feet
  • Feeling out of touch with reality

Injury

Patients taking benzodiazepines are at an excessive risk of falling or breaking bones, especially the elderly, patients taking sedatives, including alcohol.

Reporting side effects

If you notice any side effects, tell your doctor, pharmacist or pharmacist about it, including any side effects not listed in this leaflet. You can also report side effects to Arpimed LLC by going to the website www.arpimed.com and filling out the appropriate form “Report side effects or drug ineffectiveness” and to the Scientific Center for the Expertise of Drugs and Medical Technologies named afterAcademician E. Gabrielyan by going to the website www.pharm.am in the section “Report side effects of the drug” and fill out the form “Card of messages about side effects of the drug”. Scientific center hotline: +37410237665; +37498773368 By reporting side effects you are helping to gather more information on the safety of this medicine.

How to store Clonazepam

  • The drug should be stored out of the reach of children, dry, protected from light at a temperature not exceeding 25 90 126 0 90 127 90 141
  • Shelf life – 3 years.Do not take clonazepam after the expiration date printed on the drug package. The expiry date refers to the last day of the specified month.
  • Do not throw away leftover tablets. Ask your doctor or pharmacist how to dispose of a drug you no longer need. Keep the medicine with you if your doctor has instructed you to do so.
  • If the tablets are discolored or show other signs of deterioration, ask your pharmacist how to dispose of the drug.

Contents of the box and additional information

What Clonazepam contains

One tablet contains:

active substance – clonazepam – 2 mg;

excipients: microcrystalline cellulose, monohydrate lactose, corn starch, povidone, sodium starch glycolate, magnesium stearate, purified talc.

What Clonazepam looks like and contents of the pack:

White round flat tablets scored on one side.

Cardboard package containing 24 tablets (1 blister of 24 tablets) together with an enclosed leaflet.

Vacation conditions

Prescription

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